Washington has got to find a way to beat its addiction to the drug industry, which appears to have a line-item veto on national health policy. At stake in this dangerous codependency are efforts to rein in health costs, maintain the safety of our medicines and-last but not least-keep a modicum of confidence in government.
The furor over the Food and Drug Administration's possible role in keeping the painkiller Vioxx on the market long after evidence of its contribution to heart attacks surfaced is the latest side effect of the Big Pharma-Beltway boondoggle. This one, however, is a smoking gun. Nobody should, as President Bush puts it, "misunderestimate" Americans' quick temper when they figure out government has been playing fast and loose with their health in order to cozy up to free-spending special interests.
Let's remember this is the same FDA that failed to heed warnings about the risks of suicide among teenagers taking antidepressants. It's the very agency that failed to provide adequate oversight of the development of flu vaccine, endangering the health of millions. And it's the same FDA that has been trying to con people into believing that Canadian pharmacies can't deliver lower-cost U.S. drugs back to us safely.
Responding to the Merck-Vioxx story, the editors of the esteemed Journal of the American Medical Association rushed to release a series of articles that reveal Vioxx was a symptom of a larger problem. The authors of the articles provide strong evidence that Bayer Corp. knew about the dangers of Baycol, a cholesterol drug pulled from the market in 2001, for a long time before letting the FDA know the drug caused muscle deterioration.
The FDA has a terrible track record of adequately monitoring drugs after they hit the market. Here are some possible reasons: A 1992 law aimed at speeding the approval process for groundbreaking drugs augments the FDA's budget with hundreds of millions of dollars from the drugmakers. Drugmakers spent $4.9 million in 2003 just to lobby the agency. They also take advantage of lax oversight protocols to provide the FDA with only the data they think is appropriate.
The authors of the JAMA pieces argue that we need a better system to track harmful side effects of drugs on the market, one that is independent of the FDA and its drug industry cronies. A study is to be conducted by the Institute of Medicine on whether this is necessary, and the powerful Sen. Chuck Grassley (R-Iowa) is watching developments closely with an eye toward legislation mandating an independent drug reviewer.
Lest we unfairly single out the FDA, please note it is hardly alone in its special relationship with Big Pharma. As we reported last week, the CMS is helping the industry push for an expansion of the number of drug categories in the formulary for the new Medicare prescription drug benefit (Nov. 22, p. 14). The net effect is that each category will have fewer drugs, thus less chance for competition with a separate category for expensive name-brand drugs.
Congress and the Bush administration cravenly caved to the industry during the debate over the drug benefit in 2003, going out of their way to ensure that Medicare couldn't do what every other government payer in the country does-use its market power to negotiate bulk buying rates for drugs.
At some point policymakers and regulators will wake up to find out that all those millions of dollars in campaign contributions and junkets aren't worth the political cost when voters find out their health and hard-earned dollars have been used to enable this addiction. That day is fast approaching.
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